Use of Cold and Compression Therapy With Total Knee Replacement Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by CoolSystems, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
CoolSystems, Inc.
ClinicalTrials.gov Identifier:
NCT00712816
First received: July 7, 2008
Last updated: March 19, 2012
Last verified: March 2012
  Purpose

The purpose of the study is to evaluate the effectiveness of a device that delivers cold and intermittent compression as compared to ice and compressive wraps on patients who have undergone knee replacement.


Condition Intervention Phase
Osteoarthritis
Total Knee Arthroplasty
Device: Game Ready Injury Treatment System (CoolSystems Inc.)
Other: Ice with compressive bandages
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigating the Use of a Cryopneumatic Therapy Device in Primary Total Knee Arthroplasty Patients

Resource links provided by NLM:


Further study details as provided by CoolSystems, Inc.:

Primary Outcome Measures:
  • Physical function performance [ Time Frame: 2 weeks postoperative, 6 weeks postoperative, 6 months postoperative ] [ Designated as safety issue: No ]
  • Time to reach defined physical therapy milestones [ Time Frame: 2 weeks postoperative, 6 weeks postoperative, 6 months postoperative ] [ Designated as safety issue: No ]

Estimated Enrollment: 224
Study Start Date: July 2008
Estimated Study Completion Date: May 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Device: Game Ready Injury Treatment System (CoolSystems Inc.)
Cold with intermittent compression postoperatively for 2 weeks
Active Comparator: B Other: Ice with compressive bandages
Cold with static compression postoperatively for 2 weeks

Detailed Description:

The use of cryotherapy with compression for orthopedic postoperative recovery has not been fully investigated. A new device has been developed that combines cold and intermittent pneumatic compression in a single system. A well-controlled clinical study evaluating the clinical effectiveness of cryotherapy with compression in an orthopedic postoperative application is the subject of this protocol. Patients diagnosed with osteoarthritis of the knee and scheduled for primary total knee arthroplasty procedure will be invited to participate in this study.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 but no more than 85 years of age
  • Body Mass Index not greater than 40
  • Diagnosis of osteoarthritis of the knee
  • Medically cleared for total knee replacement surgery
  • Physically and mentally able and willing to participate in and follow the study protocol and schedule
  • Able and willing to have all postoperative physical therapy visits in a physical therapy clinic associated with the research site
  • Signed informed consent document for the study

Exclusion Criteria:

  • Rheumatoid arthritis
  • Severe pitting edema in the ipsilateral limb
  • History of thrombophlebitis in lower extremities
  • An active systemic disease such as AIDS, HIV, hepatitis, etc.
  • Is immunologically suppressed or has received or is receiving steroids at any dose daily for more than one month within the last 12 months
  • Is pregnant or planning to become pregnant during the study period
  • Any condition that would contraindicate using the Game Ready
  • Currently enrolled in another clinical trial that could affect outcome of this study
  • Previously enrolled in this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712816

Locations
United States, California
Naval Medical Center, San Diego
San Diego, California, United States, 92134
United States, Hawaii
Tripler Army Medical Center
Honolulu, Hawaii, United States, 96859
United States, Illinois
Central DuPage Hospital
Winfield, Illinois, United States, 60190
United States, Indiana
Orthopaedic Research Foundation
Indianapolis, Indiana, United States, 46278
United States, Maine
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
Sports Medicine Associates of San Antonio
San Antonio, Texas, United States, 78240
United States, Washington
Madigan Army Medical Center
Tacoma, Washington, United States, 98431
Australia, New South Wales
Orthosports
Concord, New South Wales, Australia, 2137
Sponsors and Collaborators
CoolSystems, Inc.
  More Information

No publications provided

Responsible Party: CoolSystems, Inc.
ClinicalTrials.gov Identifier: NCT00712816     History of Changes
Other Study ID Numbers: 2007-02
Study First Received: July 7, 2008
Last Updated: March 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by CoolSystems, Inc.:
osteoarthritis
total knee arthroplasty
cryotherapy

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 23, 2014